Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK

Objective To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been...

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Main Authors: Derek J Ward, Andrew J Stevens, Sue Simpson, Orsolina I Martino
Format: Article
Language:English
Published: BMJ Publishing Group 2013-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/3/2/e002088.full
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author Derek J Ward
Andrew J Stevens
Sue Simpson
Orsolina I Martino
author_facet Derek J Ward
Andrew J Stevens
Sue Simpson
Orsolina I Martino
author_sort Derek J Ward
collection DOAJ
description Objective To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.Design Retrospective observational study.Setting and data source Database of new preparations added annually to the British National Formulary (BNF).Main outcome measures The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.Results There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.Conclusions The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.
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spelling doaj-art-7d8e73f8ff3141fe900a024db5a499fe2025-08-20T03:11:06ZengBMJ Publishing GroupBMJ Open2044-60552013-02-013210.1136/bmjopen-2012-002088Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UKDerek J Ward0Andrew J Stevens1Sue Simpson2Orsolina I Martino3Institute of Applied Health Research, University of Birmingham, Birmingham, UKprofessor of public health.1NIHR Horizon Scanning Centre, University of Birmingham, Birmingham, UK1NIHR Horizon Scanning Centre, University of Birmingham, Birmingham, UKObjective To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.Design Retrospective observational study.Setting and data source Database of new preparations added annually to the British National Formulary (BNF).Main outcome measures The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.Results There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.Conclusions The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.https://bmjopen.bmj.com/content/3/2/e002088.full
spellingShingle Derek J Ward
Andrew J Stevens
Sue Simpson
Orsolina I Martino
Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
BMJ Open
title Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
title_full Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
title_fullStr Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
title_full_unstemmed Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
title_short Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK
title_sort decline in new drug launches myth or reality retrospective observational study using 30 years of data from the uk
url https://bmjopen.bmj.com/content/3/2/e002088.full
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AT suesimpson declineinnewdruglaunchesmythorrealityretrospectiveobservationalstudyusing30yearsofdatafromtheuk
AT orsolinaimartino declineinnewdruglaunchesmythorrealityretrospectiveobservationalstudyusing30yearsofdatafromtheuk